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NCT Number: NCT04968470

SEBBIN Silicone Gel-filled Testicular Implants

This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.

Recruiting

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Key information

Conditions

Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Durability Prosthesis Failure

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Gent, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient is an adult or a child at the time of implant placement with SEBBIN implant.
  • The patient is candidate to a unilateral or bilateral testicular implant placement with SEBBIN implant.
  • The patient has been informed of the study, has read the patient information letter and -provided oral consent.

Exclusion criteria

  • The patient has silicone implants somewhere else than in the scrotal sac.
  • The patient was diagnosed with one of the following pathologies:
  • Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.
  • Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.
  • Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.
  • The patient has a pathology that could delay healing.
  • Custom-designed implants are used for surgery.

Treatment and study plan

Primary outcomes

  1. Complication rate

    Time frame: At 10 years of follow-up

Sponsors and collaborators

Lead sponsor

Groupe SEBBIN

Industry

Registry information

Official study title

Prospective Observational Study About SEBBIN Silicone Gel-filled Testicular Implants

Important dates

Study start
2021
Primary completion
2025
Study completion
2035
First posted
Jul 20, 2021
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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